Pragmatically, they are anticipating mesenchymal. I’d imagine since they probably did not complete any prior unblinded looks, this could still have been added as a subgroup. Probably a little more complicated than you describe matters.
I am split on your opinion. I believe statistically significant subgroups should be given conditional approval with a well defined Phase 4 followup confirmation time line and endpoints unlike current structure that basically allows all comers a free pass except under the rarest of conditions.
I get what Linda is arguing about statistical significance for but I agree with you that ignoring it opens up too many doors for abuse at this point. An overwhelming consensus for when parameters outside of statistical significance might be utilized needs to be developed first. Funny how Linda left her mark on the comment with the word "whammy" and the style of writing. Best wishes.
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